Company ยท CN
Guangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) Guangdong Newdermo Biotech Co., Ltd., CN | NFO |
| Jun 29, 2026 | K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Jun 18, 2026 | K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Mar 23, 2026 | K260202 | LED Light Therapy Masks (LumiLips FAC07NA) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Feb 23, 2023 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||